FDA Adverse Event
Malfunction
Summary report: N
ENTERRA
MDR report key: 1926033
·
Received November 10, 2010
Report
- Report Number
- 3004209178-2010-09213
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- January 1, 2010
- Report Date
- October 22, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT'S MOTHER ASKED WHY HER DAUGHTER'S NEUROSTIMULATOR BATTERY DID NOT LAST LONGER THAN FOUR YRS. THE PT DID NOT EXPERIENCE ANY FALLS OR OTHER TRAUMAS. NO PT SYMPTOMS WERE REPORTED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERRA | LNQ | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3116 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | IMPLANTED:| EXPLANTED:| LEAD: MODEL 4351, LOT# NHT000981N| LEAD: MODEL 4351, LOT# NHT000970N| EXPLANTED:| IMPLANTED: |